Shock wave aerosolization apparatus and method

ABSTRACT

A pneumatic inhaler that is able to deliver a controlled burst or dose of aerosol from a reservoir of liquid or powder medication. A supersonic jet of gas is emitted from a nozzle and shock waves are developed in the jet. In one embodiment the supersonic jet is directed into a shock chamber. Liquid or micronized powder material is introduced into the supersonic jet to form an aerosol. In one embodiment, smaller aerosol particles are separated from larger aerosol particles with a separator. In another embodiment, the produced aerosol is contained in an aerosol storage chamber prior to inhalation by the users.

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application is a continuation-in-part of U.S. applicationSer. No. 09/963,886 filed on Sep. 25, 2001, which claims priority toU.S. provisional application serial No. 60/305,088 filed on Jul. 12,2001 and to U.S. provisional application serial No. 60/235,597 filed onSep. 25, 2000. This application also claims priority to U.S. provisionalapplication serial No. 60/389,048 filed on Jun. 13, 2002, incorporatedherein by reference.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

[0002] Not Applicable

INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A COMPACT DISC

[0003] Not Applicable

BACKGROUND OF THE INVENTION

[0004] 1. Field of the Invention

[0005] This invention pertains generally to aerosol generating devices,and more particularly to inhalers that may be used to dispense liquid orpowder medication in short bursts of aerosol.

[0006] 2. Description of the Background Art

[0007] Some medicines cannot withstand the environment of the digestivetract and must be delivered to the bloodstream of the patientintravenously or by some other method. One effective means for deliveryof such medications to the blood stream is through the membranes and airpassageways of the lung.

[0008] Inhalers of various types have been widely used for inhalationdelivery of aerosols containing medication or other constituents to theconductive airways of the lung and the gas exchange regions of the deeplung. Aerosols are relatively stable suspensions of finely divideddroplets or solid particles in a gaseous medium. When inhaled, aerosolparticles may be deposited by contact upon the various surfaces of therespiratory tract leading to the absorption of the particles through themembranes of the lung into the blood stream to provide the desiredtherapeutic action, or planned diagnostic behavior depending on theparticular properties of the particles.

[0009] Because of the high permeability of the membranes of the lung andthe copious flow of blood through the lung, medications deposited in thelung can readily enter the blood stream for delivery throughout thebody. This may also allow for the use of lower initial doses than wouldnormally be required to be taken orally to achieve the desiredconcentration of medication in the blood. Other medications can directlyinfluence the airway epithelium and effect responses via various airwayreceptors. Still other types of aerosol particles deposited in the lungcan act as tracers of airflow or indicators of lung responses and canotherwise be a valuable diagnostic tool. Properly generated andformulated aerosols can therefore be helpful in medical treatment.Inhalable aerosol particles capable of deposition within the lung aretypically those with an aerodynamic equivalent diameter of between 1 and5 micrometers.

[0010] Early attempts at producing an inhalation medical treatmentinclude the use of atomizers. Atomizers are typically equipped withreservoirs, nozzles, and bulbs. Upon squeezing the bulb, liquidmedication, which is placed within the reservoir, is drawn from thereservoir and sprayed by the nozzle for inhalation by the patient.However, the particle size produced by atomizers is too large foreffective deposition in the lungs, although variants of the techniqueare still used for deposition of topical medication into the nasalcavity and associated tissues. A further disadvantage of atomizers isthat they are unable to deliver a consistent dose due to discrepanciesin user technique and the duration of each burst. Accordingly, atomizersare appropriate for delivery of medication to the sinus cavity, wherethe larger aerosol particle size is more effective for deposition butinappropriate for deposition in the deep lung.

[0011] Inhalers known in the art employ several techniques to achieveeffective aerosolization of medicines for deposition in the lung. Aninhaler produces a burst of aerosol consisting of fine particlesintended for inhalation by a patient with a single breath. Inhalers arepopular aerosol delivery devices because they are generally portable andare convenient to use. The particle size of the aerosol emitted from atypical inhaler is required to be considerably smaller than aconventional spray atomizer to ensure the appropriate deposition withinthe lungs.

[0012] Commonly, inhalers are pre-packaged containers containing amixture of medication to be aerosolized and a low saturation pressurevapor or gas, such as chlorofluorocarbons (CFCs), which are used as apropellant. The canister carrying the mixture of the medication and thepropellant is equipped with a valve. When the valve is actuated, theinhaler dispenses a set amount of liquid and medication through anozzle, creating a spray. Upon release into the atmosphere, the lowsaturation pressure propellant is able to evaporate quickly leavingsmall aerosol particles of medication that are suitable for immediateinhalation. One disadvantage to this approach is that the propellant andthe medication must be mixed for a significant period of time prior toinhalation by the patient, making them unsuitable for many medications.Furthermore, the pre-mixing of the medication and the propellantrequires a different approach to gain regulatory approval, necessitatingsignificant development time and capital, thereby significantlyincreasing the ultimate cost to the patient over the cost of liquidformulations of same medication. Furthermore, to prevent agglomerationof the medication within the canister, surfactants are also added to theformulation, which often leave an undesirable taste in the mouth of thepatient after inhalation. Lastly, this approach is generally unsuitablefor medications requiring large quantities of medication to achieveefficacious results.

[0013] Another inhaler strategy that is being employed with greaterfrequency is the aerosolization of dry medicament powders. Medicinalpowders are prepared in advance and placed in a reservoir within theinhaler, or within blister pouches. Blister pouches have the advantageof being able to better preserve the powder from contamination andmoisture. When the patient is ready for a dose of medication, theyeither access the reservoir to dispense an appropriate amount ofpowdered medication, or puncture a blister pouch containing the powdermedicament.

[0014] Aerosolization of powders is typically achieved by the gas flowproduced by the inhalation of the patient. However, the aerosolizationof medicinal powders is plagued by problems of moisture contaminationand the inconsistencies in inhalation effort by the patient from dose todose. Furthermore, powder formulations are often as expensive to developas pre-mixed propellants and may require complex, sophisticated andexpensive manufacturing processes in their production. In addition, manymedications are not effective after reformulation as a powder. Finally,powder aerosolization may be ineffective due to the appearance of anelectric charge build up on the individual powder particles causingparticles to attach to other particles or to the delivery device. Recentstudies using inhaled powder medications have indicated that problems ofpulmonary fibrosis may exist when treating chronic conditions withinhaled powder medication.

[0015] A third inhaler strategy employs ultrasonic energy to aerosolizebursts of liquid medication. These devices require precise electronicvalves and associated electronic circuitry, making them expensive tomanufacture and prone to malfunction. Additionally, the particle size ofthe aerosol produced by these devices is often too large for optimaldeposition in the lung. Large and inconsistent aerosol particle sizeproduction by the inhaler results in an inconsistent and inefficientdelivery of the medication to the lung.

[0016] Additionally, ultrasonic inhalers using piezo-electric crystalsto create aerosolization of the medicine are often not suitable fordelivering proteins, peptides and antibodies and the like because of thedamage and loss of biological activity that occurs with ultrasound.Other medicines have required expensive reformulizations in order to bedelivered by the ultrasonic aerosolization method. Lastly, ultrasonicinhaler technologies have been shown to have difficulties in deliveringconcentrated medication, making them suitable for potent medicationsonly, and unsuitable for the delivery of medication requiring largequantities of medication to be efficacious.

[0017] Therefore, a need exists for a technology which can deliveraerosol bursts of liquid medication at a particle size that isappropriate for lung deposition which is inexpensive for the patient,produces consistent output, uses a formulation which is inexpensive todevelop and produce, that is reliable, that is easy to use, which doesnot require the mixing of medication and propellant until the moment ofaerosolization, and which can deliver large quantities of medicationwhen needed. The present invention satisfies this need, as well asothers and has the further advantages of providing superior aerosolquality, and being lightweight and portable.

BRIEF SUMMARY OF THE INVENTION

[0018] The present invention generally pertains to a pneumatic metereddose inhaler that is able to deliver a controlled burst or dose ofaerosol from a reservoir of liquid medication. The invention isappropriate for the aerosolization of liquid medication that is insolution or in suspension form. The invention is also ideal for thedelivery of unique and specialty liquid medications in short aerosolbursts because no additional formulation development is needed. Theapparatus has the further advantage of being able to deliver multiplemedications, as mixed by the patient, doctor, or pharmacist, with asingle burst of aerosol at a repeatable output. Because the medicationand the propellant are not mixed until aerosolization occurs, thecurrent invention is appropriate for more pharmaceutical agents than canbe used by currently available inhalers at a substantial cost savings.

[0019] According to one aspect of the invention, an apparatus and methodare provided for producing an aerosol suspension that comprisesdirecting a flow of gas through a nozzle to form a supersonic jet of gasand then introducing material into the supersonic jet of gas to producean aerosol suspension.

[0020] According to another aspect of the invention, an apparatus forproducing shock wave aerosolization is provided that has a source ofcompressed gas and a nozzle configured to generating a supersonic jet ofgas from the source of compressed gas.

[0021] Another aspect of the invention provides a sonic shock chamberthat is configured to receive the supersonic jet of gas from the nozzle.Compression and expansion shock waves created by the supersonic jet arereflected within the confines of the expanding supersonic jet.

[0022] According to another aspect of the invention, an apparatus isprovided that has an actuator handle with a compressed gas container anda user actuated valve configured to release the compressed gas inbursts. The apparatus also has a jet orifice configured to receivecompressed gas from the gas container and produce a supersonic jetdirected through a sonic shock chamber to produce shock waves. A sourceof material for aerosolization associated with the jet orifice and shockchamber is also provided and introduced into the burst of compressed gascreating aerosol particles.

[0023] According to yet another aspect of the invention, an aerosolseparator is provided that separates large aerosol particles from smallaerosol particles that have been produced.

[0024] According to another aspect of the invention, the aerosolseparator is also configured to reflect acoustic energy from thesupersonic jet of gas to the produced aerosol particles and reduce thesize of the larger aerosol particles emitted from the jet.

[0025] According to still another aspect of the invention, a means forstoring separated aerosol particles is provided.

[0026] By way of example and not of limitation, a first embodiment ofthe present invention employs a cartridge or cylinder for containingvirtually any type of compressed gas. Typically, carbon dioxide gas isused at a preferred pressure of approximately 750 psi, because the gashas a low critical temperature and pressure, allowing a small canisterto carry significantly more than if filled with many other gases. Thecompressed gas is released in small bursts by a valve actuated by thepatient, which delivers the gas to the supersonic shock nozzle. Thenozzle comprises a jet orifice from which the compressed gas dischargesinto a sonic shock chamber. Provided that substantial backpressure issupplied, a supersonic jet of gas exits from the jet orifice of thenozzle, which may be over expanded, under expanded or perfectlyexpanded. If the jet is over or under expanded, the supersonic jet,which remains at approximately the diameter of the jet orifice and whichtravels down the axis of the shock chamber and establishes a series ofreflected compression and expansion shock waves. A perfectly expandedjet will have a cylindrical shock wave that envelops the entire jet.Although this would be preferable for the production of aerosol, it isoften impractical as a result of variations in gas supply pressure andthe desired dimensional scale of the preferred embodiment of the currentinvention. Therefore, the nozzle is designed to provide a jet that isover expanded in one embodiment, and this may be considered optimum.

[0027] Upon formation of the jet and the resulting reflected shock wavesin the shock chamber, a vacuum is generated which causes liquid, forexample, from the reservoir to be entrained through the liquid feedchannels into the shock chamber. The preferred liquid feed channelsdirect the incoming fluid circumferentially around the nozzle andentrance to the shock chamber. Upon entrainment of the liquid to theshock chamber, the initially entrained liquid comes in contact with theshear forces created by the shock waves, producing abundant amounts ofaerosol particles suitable for inhalation. Shock waves are uniquely ableto produce tremendous quantities of aerosol with good particle size forinhalation because they have the property of having large pressuredifferences over very small distances, thus making them able to generatesubstantial shear forces. The result of liquid traveling across thisshock boundary is to be violently and physically disturbed, thusdisintegrating into a dense burst of aerosol with appropriate particlesize for inhalation. This represents a significant advance overtraditional atomizers, which lacked the ability to introduce medicationto shock waves of any design or magnitude, resulting in lower output andlarger particle size.

[0028] Once the liquid has been entrained into the shock chamber andjet, the integrity of the jet and resulting reflecting shock waves maybe destroyed, resulting in a reduction in the subsequent production ofaerosol particles than is produced in the initial burst. The volume andrate of liquid or other material that is entrained in the jet istherefore preferably regulated. The subsequent production of aerosolalso has a generally larger particle size than the initial burst. Theoverall result is an initial burst of aerosol ideally suited for aninhaler, generally lasting less than a second, depending on the rate ofmedication introduction to the jet. The output and particle size of suchan inhaler is substantially better than would be predicted from thesteady state operation of an atomizer or nebulizer nozzle of similardesign. It is not possible to employ the same technique in the designand manufacture of an atomizer or nebulizer, because these devices areintended to run continuously and the unique phenomena of the currentinvention only occurs with the controlled introduction of fluids to thereflected shock waves. Since the aerosolization process is so efficient,only a little volume of compressed gas is required for a burst ofaerosol, making it possible, and efficient, to store enough carbondioxide in a small canister for 200 bursts or more.

[0029] Although not optimum under many conditions, a similar result isobtained by providing a shock region instead of a shock chamber. In thisembodiment, the supersonic jet of gas exits directly into a generallyopen region allowing for the formation of reflected shock waves withinthe exiting jet. Liquid is entrained through one or more feed tubesplaced proximally to the jet at a sufficient distance to generate avacuum. Again, once the entrained liquid comes into contact with thereflected shock waves, a tremendous amount of aerosol particles areproduced, and the integrity of the sonic jet and the shock waves isdestroyed. Based on experimentation, such an approach was not found tobe optimum because it did not allow for the precise introduction offluid to the shock waves, which affects the output and particle size ofthe resulting aerosol burst. It should be noted that such an open designdoes have distinct advantages for thick, viscous fluids, because of thepotential of clogging involved with the closed design of the previousembodiment due to the difficulty of cleaning.

[0030] In addition, the aerosolization process can be further optimizedthrough placement of a liquid feed choke between the fluid reservoircontaining the medication, and the liquid feeds that lead into the shockchamber or shock region. By further choking the flow of liquid down, itis possible to better control the introduction of fluid into thesupersonic jet produced in the shock chamber, thus allowing for betteraerosolization and an increase in the duration of the aerosol burst,although it is still generally a momentary phenomena relative to normaljet nebulization technologies.

[0031] The preferred embodiment of the current invention draws liquidfrom a reservoir of medication that is preferably sufficient to holdapproximately 200 doses, and has been shown to produce consistent dosesof aerosolized liquid medication. In the event that extremely precisedosing is desired, or if a change in dosing is desired from burst toburst, one embodiment of the current invention may be modified toconsist of a small reservoir, or multiple small reservoirs, that containthe exact amount of liquid desired for delivery, and which is less thanthe nozzle will entrain with a given burst, or predetermined series ofbursts. Thus, the output of the inhaler is exactly equal to the contentsof the reservoir, and may be easily changed from dose to dose.

[0032] Another embodiment of the invention includes the use of blisterpacks pre-filled with the exact amount of liquid intended foraerosolization rather than the use of a reservoir. Prior to the contentsof a blister cell being delivered, a feed tube, which is in fluidcommunication with the supersonic shock nozzle, is caused to punctureand penetrate the blister cell. Upon actuation of the nozzle, thecontents of the blister cell is completely entrained into the shocknozzle and aerosolized. Blister packs also have the added advantage ofbetter preserving medication than multiple dose reservoirs due to thelimited exposure of the medication to air prior to aerosolization.

[0033] Once the entrained liquid is aerosolized, the momentum of the jetcarries the aerosol into a mouthpiece for immediate inhalation by thepatient. Depending on the ability of the patient to coordinate actuationand inhalation, and the desired portion of the lung targeted fordeposition, a spacer or valved holding chamber may be attached to themouthpiece.

[0034] In another embodiment, spacers or chambers allow for easiercoordination of patient's inhalation with device actuation and separateout comparatively smaller aerosol particles from larger aerosolparticles that are inappropriate for deposition within the lung.Separation of smaller aerosol particles and a momentary delay ininhalation allows more time for the liquid aerosol particles toevaporate, producing superior sized aerosol particles (1-3 microns) fordeposition in the alveolar portions of the lung.

[0035] In another embodiment, the aerosol particles that are producedare directed to a shock wave amplification chamber that reflectsacoustic energy from the supersonic jet through the aerosol particlesand reduces the size of the particles. The chamber also preferablyseparates the larger aerosol particles from the smaller aerosolparticles.

[0036] Optionally, the exiting aerosol from the jet or the separatedaerosol may be stored in an aerosol holding chamber. In one embodiment,the holding chamber stores aerosol upon actuation for subsequentinhalation. The chamber preferably has a valve that allows ambient airto be drawn into the holding chamber when the user inhales the aerosolthrough the mouthpiece. Additionally, as is well known in the industry,and recently reported during in-vitro investigations (Respiratory Care,June 2000, Volume 45, Number 6, “Consensus Conference on Aerosols andDelivery Devices”, page 628), valved chambers often maintain a staticelectric charge due to rinsing with water that causes a significant lossof aerosol particles due to mutual static electric attraction. Oneembodiment preferably employs an anti-static plastic that prevents thisphenomenon from occurring.

[0037] Additionally, the shock wave aerosolization process functionsremarkably well with micronized powder in blister packs as well. Blisterpacks, containing one or more cells, are used to store a pre-determinedamount of powder. Prior to aerosolization, a feed tube, which is influid communication with the shock wave aerosolization process nozzle,is inserted into the blister pack cell. Subsequent to the insertion ofthe feed tube, the carbon dioxide valve is actuated, creating a setburst of gas. As previously described, the carbon dioxide exits thethroat of the jet, causing a vacuum, which entrains the micronizedpowder through the feed tube and into the shock chamber. As previouslydescribed with liquid medication, when medicinal powder is entrained itbecomes efficiently aerosolized in the reflected shock waves and carriedout to the mouthpiece or valve chamber, as intended.

[0038] An object of the invention is to provide an inhaler that candeliver a repeatable dose of aerosol containing particles appropriatelysized for deposition within the patient's lung.

[0039] Another object of the invention is to provide an inhaler that canproduce aerosol particles appropriate for deposition in the bronchialairways.

[0040] Another object of the invention is to provide an inhaler that canproduce aerosol particles appropriate for deposition in the alveolarportions of the lung.

[0041] Another object of the invention is to provide an inhaler that canaerosolize an aqueous solution.

[0042] Another object of the invention is to provide an inhaler that canaerosolize a suspension of medication in liquid.

[0043] Another object of the invention is to provide an inhaler that canaerosolize liquid pharmaceutical formulations and peptides currentlyavailable only for nebulizers.

[0044] Another object of the invention is to provide an inhaler thatdoes not mix medication and propellant prior to aerosolization.

[0045] Another object of the invention is to provide an inhaler that candeliver combinations of different medications with one burst.

[0046] Another object of the invention is to provide an inhaler with anacceptable aftertaste.

[0047] Another object of the invention is to provide an inhaler that isportable, convenient and easy to use.

[0048] Another object of the invention is to provide an inhaler that isinexpensive to produce.

[0049] Another object of the invention is to provide an inhaler that hasa built in valved chamber for storage of aerosol.

[0050] Another object of the invention is to provide an invention thatworks in conjunction with blister packs that contain either liquid orpowder.

[0051] Another object of the invention is to provide an invention thatworks in conjunction with concentrated and viscous medications.

[0052] Further objects and advantages of the invention will be broughtout in the following portions of the specification, wherein, thedetailed description is for the purpose of fully disclosing preferredembodiments of the invention without placing limitations thereon.

BRIEF DESCRIPTION OF THE DRAWINGS

[0053] The invention will be more fully understood by reference to thefollowing drawings that are for illustrative purposes only:

[0054]FIG. 1 is a side view of a first embodiment of a metered doseinhaler according to the present invention.

[0055]FIG. 2 is a perspective view of the inhaler of FIG. 1.

[0056]FIG. 3 is a side view in longitudinal cross-section of the inhalerof FIG. 1.

[0057]FIG. 4 is a perspective view of the actuator portion of theinhaler of FIG. 1.

[0058]FIG. 5 is a side view in cross-section of the actuator of FIG. 4.

[0059]FIG. 6 is a detail side view in cross-section showing the valveportion of the actuator of FIG. 4 in the actuated state.

[0060]FIG. 7 is a perspective view of the aerosol generator portion ofthe inhaler of FIG. 1.

[0061]FIG. 8 is a detail side view in cross-section of the aerosolgenerator of FIG. 7 taken along the lines 8-8 of FIG. 7.

[0062]FIG. 9 is a detail side view in cross-section of the nozzleportion of the aerosol generator of FIG. 7 and FIG. 8.

[0063]FIG. 10 is a rendering of an over expanded supersonic jettypically produced by the inhaler of FIG. 1.

[0064]FIG. 11 is a schematic representation of the over expandedsupersonic jet of FIG. 11.

[0065]FIG. 12 is a front view of aerosol generator of FIG. 7 showing themouthpiece and plug.

[0066]FIG. 13 is an exploded view of a second embodiment of an inhaleraccording to the present invention showing the reusable actuator handle,aerosol generator, and carbon dioxide cartridge.

[0067]FIG. 14 is a perspective view of the disposable carbon dioxiderefill cartridge portion of the inhaler of FIG. 13.

[0068]FIG. 15 is an exploded view of the carbon dioxide canister of FIG.14.

[0069]FIG. 16 is a perspective view of the reusable inhaler actuatorportion of the inhaler of FIG. 13.

[0070]FIG. 17 is an exploded view of the reusable actuator of FIG. 16.

[0071]FIG. 18 is a perspective view of the valve portion of the inhalerof FIG. 13 and FIG. 17.

[0072]FIG. 19 is an exploded view of the valve of FIG. 18.

[0073]FIG. 20 is a side view in cross-section view of the valve of FIG.18.

[0074]FIG. 21 is a perspective view of the disposable inhaler aerosolgenerator portion of the inhaler embodiment of FIG. 13.

[0075]FIG. 22 is an exploded view of the aerosol generator of FIG. 21.

[0076]FIG. 23 is a perspective view of the jet employed in the inhalerof FIG. 13 and FIG. 22.

[0077]FIG. 24 is a perspective view of the top side of the secondaryemployed in the inhaler of FIG. 13 and FIG. 22.

[0078]FIG. 25 is a perspective view of the bottom side of the secondaryshown in FIG. 24.

[0079]FIG. 26 is a perspective view of the cap employed in the inhalerof FIG. 13.

[0080]FIG. 27 is a perspective view of the column base employed in theinhaler of FIG. 13 and FIG. 22.

[0081]FIG. 28 is a perspective view of the end of the column of FIG. 22.

[0082]FIG. 29 is an assembled perspective view of the inhaler embodimentof FIG. 13.

[0083]FIG. 30 is a side view in cross-section of the inhaler of FIG. 13and FIG. 29.

[0084]FIG. 31 is a detail side view in cross-section of the supersonicnozzle assembly portion of the inhaler of FIG. 13.

[0085]FIG. 32 is a detail side view in cross-section of the jet andshock chamber portion of the nozzle assembly of FIG. 31.

[0086]FIG. 33 is a side cross sectional view of an alternative andpreferred embodiment of the entire invention.

[0087]FIG. 34 is a sectional view of an alternative embodiment of anaerosol generator with a shock wave amplification chamber according tothe present invention shown in FIG. 33.

[0088]FIG. 35 is a side cross-sectional view of an aerosol generatorwith an alternative embodiment of a shock wave amplification chamberaccording to the present invention.

[0089]FIG. 36 is a cross sectional view of an alternative embodiment ofthe CO₂ burst valve according to the present invention.

[0090]FIG. 37 is an exploded view of an embodiment of a blister packaerosol generator according to the present invention.

[0091]FIG. 38 is an exploded cross-sectional view of a blister packaerosol generator shown in FIG. 37.

[0092]FIG. 39A is a cross-sectional view of a blister pack aerosolgenerator of FIG. 38 with the safety strip in place.

[0093]FIG. 39B is a cross-sectional view of a blister pack aerosolgenerator of FIG. 38 with the safety strip removed and the blister packpunctured.

[0094]FIG. 40 is a perspective view of a blister pack aerosol generatorof FIG. 37.

[0095]FIG. 41 is a perspective view of an actuator containing a blisterpack aerosol generator with the trigger in the open position.

[0096]FIG. 42 is a side view in cross-section of an alternativeembodiment of an inhaler according to the present invention employing adisposable cartridge containing both the nozzle and a blister pack ofmedication.

DETAILED DESCRIPTION OF THE INVENTION

[0097] Referring more specifically to the drawings, for illustrativepurposes the present invention is seen in the embodiments generallyshown in FIG. 1 through FIG. 42.

[0098]FIG. 1 through FIG. 3 shows the overall configuration of a firstembodiment of a shock wave aerosolization apparatus according to thepresent invention. The inhaler portion of the apparatus comprises twoprimary parts; an actuator 12 shown in FIG. 4, FIG. 5, and morespecifically in FIG. 6, and an aerosol generator 14 shown in FIG. 7,FIG. 8 and more specifically in FIG. 9 and FIG. 12. FIG. 10 and FIG. 11are for illustrative purposes regarding the nature of reflected shockwaves in a supersonic jet. FIG. 13 and FIG. 29 show the overallconfiguration of a second embodiment of the invention. FIG. 14 and FIG.15 show the gas canister assembly. FIG. 16 through FIG. 20 details theactuator handle assembly and metered gas valve. FIG. 21 through FIGS.28, 31 and 32 shows the aerosol generator assembly of the secondembodiment. FIGS. 29 and 30 shows the configuration of the apparatusduring use.

[0099] A third alternative embodiment of the invention with a shock waveamplification chamber aerosol separator and trigger is shown in FIGS. 33through 34, and alternatively in FIG. 35.

[0100] A fourth embodiment of the invention with a blister pack medicinereservoir system is shown in FIG. 36 through FIG. 41. The alternativeembodiment of the invention shown in FIG. 42 employs a supersonic shocknozzle assembly enclosed in a small disposable cartridge along with asingle blister pack 484 containing sufficient medication for one aerosoltreatment.

[0101] It will be appreciated that the several embodiments of theapparatus may vary as to configuration and as to details of the parts,and that the method may vary as to details of steps and their sequence,without departing from the basic concepts as disclosed herein.

[0102] Referring now to FIG. 1, the aerosolization apparatus 10 of thepresent invention generally includes an actuator 12 and an aerosolgenerator 14. The actuator 12 and the aerosol generator 14 are separablecomponents in the embodiment shown, however, it will be understood thatthese components may be fully integrated and inseparable.

[0103] As seen in FIG. 2 and FIG. 3, the actuator 12 of apparatus 10 hasa handle 16 that is preferably configured to fit in the notch betweenthe thumb and first finger of the hand of the user and gripped. In theembodiment shown, the actuator 12 has a trigger 18 that pivots abouttrigger pin 20 and is brought toward the body of actuator 12 by thefingers of the user to actuate the device. The actuator 12 also has acap 22 enclosing a gas canister that can be removed from the body of theactuator 12 as needed.

[0104] The aerosol generator 14 is operably coupled with actuator 12 andprovides aerosolized medications to a user through a mouthpiece 24 whenthe trigger 18 is depressed. Medicine is disposed within a reservoirthrough a port that is sealed with a plug 26.

[0105] Turning now to FIG. 3, a cross section of the apparatus 10 withthe actuator 12 coupled with the aerosol generator 14 is shown. Theprimary components of the actuator 12 are the handle 16, cap 22, gascanister 28, trigger 18, valve body 30, valve poppet 32, and valvespring 34. Carbon dioxide in a conventional gas canister 28 is used forillustration in the embodiment shown in FIG. 3. Gas canister 28 isdisposed within handle 16 and is held in place by cap 22.

[0106] The primary components of the aerosol generator 14 are reservoir38, mouthpiece 24, aerosolization nozzle 36 and plug 26. It can be seenthat canister 28 provides a source of supply of gas to the aerosolgenerator 14 that is regulated by poppet 32. Gas from the canister 28 isdirected through the aerosolization nozzle 36, mixed with medicine fromreservoir 38 and out through the mouthpiece 24 to the user.

[0107] Referring also to FIG. 4 and FIG. 5, the aerosol generator 14 isreleasibly coupled with the actuator 12. The aerosol generator 14component can be quickly removed from the actuator 12 for refilling andcleaning. Likewise, different medications can be administeredsequentially to a single patient by removing the first aerosol generator14 after the first dosage is administered and replacing it with a secondaerosol generator 14 that has a different medication. Thus, it can beseen that a practitioner can administer appropriate medications to anynumber of patients using one actuator 12 and a number of differentaerosol generators 14 specially prepared for each patient.

[0108] Turning now to FIG. 4, FIG. 5 and more specifically FIG. 6,actuator 12 is shown without the aerosol generator 14 in place. It willbe seen that the actuator 12 is a source of gas supply that can beregulated by the actions of poppet 32 actuated by trigger 18. A meteredvolume of gas is produced to the aerosol generator 14 from the source ofsupply by the linear movement of poppet 32.

[0109] When cap 22 is removed from handle 16, a carbon dioxide canister28 can be placed into cap 22 and then inserted into the internal spaceof handle 16. With the tightening of cap 22, carbon dioxide canister 28is caused to be punctured by hollow prong 40, which is part of valvebody 30, and thereafter the canister is sealed against canister o-ring42.

[0110] Once punctured and sealed, carbon dioxide canister 28 is in fluidcommunication with valve poppet 32 disposed within valve poppet chamber46 through canister conduit 44 within hollow prong 40 and the wall ofvalve body 30.

[0111] Valve poppet 32 comprises a trigger head 48 with an actuating camsurface 50 that smoothly engages trigger 18 through the full range ofmotion of the trigger pull. The poppet 32 is biased to the far left or“rest” position, as shown, by spring 34, such that shoulder 54 is causedto rest against stop plate 56. Spring 34 preferably fits within a springindent 58 at the distal end of poppet 32.

[0112] The valve poppet in the activated position is shown in FIG. 6. Itwill be seen that valve poppet 32 is caused to move to the right, or“actuated” position, when trigger 18 is squeezed, resulting in forcebeing applied to actuating cam surface 50 of trigger head 48 of poppet32 in opposition to the force of valve spring 34.

[0113] The body 52 of poppet 32 preferably has a first o-ring groove 60,a second o-ring groove 62, and a third o-ring groove 64 that are matedwith first o-ring 66, second o-ring 68, and third o-ring 70respectively. The poppet body 52 also has a charging volume groove 72,preferably positioned between the second o-ring groove 62 and the thirdo-ring groove 64. First o-ring groove 60, second o-ring groove 62, thirdo-ring groove 64, and charging volume 72 all consist of geometry whichis circumferential to valve poppet 32, which is generally cylindrical inshape. O-rings 66, 68 and 70 are all made preferably of urethane, whichis compatible with high-pressure carbon dioxide or other delivery gas orcombination of gases.

[0114] Although o-rings are preferred, it will be understood that otheralternative sealing means known in the art may also be used to eliminateleakage of gas from the canister conduit 44 into poppet chamber 46 andout of the apparatus.

[0115] Referring more particularly to FIG. 5, it can be seen that whenvalve poppet 32 is in the rest position, as shown, the internal gaspressure of carbon dioxide canister 28 is in fluid communication withcharging volume 72 and the space between poppet 32 and the walls ofpoppet chamber 46, between o-rings 68 and 70 through canister conduit44, resulting in charging volume 72 being filled with carbon dioxide tothe same pressure that is in carbon dioxide canister 28. The contents ofcarbon dioxide canister 28, and charging volume 72, is prevented fromescaping around the valve poppet 32 into the ambient environmentprimarily by second o-ring 68 and third o-ring 70 that seal the sectionsof the chamber 46 between the o-rings.

[0116] As valve poppet 32 is moved into the actuated position, as shownin FIG. 6, second o-ring 68 passes over canister conduit 44, preventingfurther fluid communication between carbon dioxide canister 28 andcharging volume 72, and third o-ring 70 is caused to pass over valveexit conduit 74, thus releasing the pressurized gas in charging volume72 through valve exit conduit 74 to valve exit port 76. Second o-ringgroove 62 and third o-ring groove 64 are preferably spaced apart fromcharging volume 72 so that the second o-ring 68 terminates fluidcommunication between carbon dioxide canister 28 and charging volume 72prior to the third o-ring 70 passing over valve exit conduit 74, thuspreventing the contents of carbon dioxide canister 28 from ever being influid communication with valve exit conduit 74 and valve exit port 76,and creating a burst of pressurized gas to be released from chargingvolume 72.

[0117] Obviously, charging volume 72 may be sized for different volumesallowing for different amounts of gas such as carbon dioxide to bereleased with each actuation. It will also be seen that first o-ring 66prevents escape of contents of carbon dioxide canister 28 around valvepoppet 32 into the ambient environment when valve poppet 32 is in theactuated position.

[0118] As shown in FIG. 1, FIG. 2, and FIG. 3, aerosol generator 14 iscaused to mate with actuator handle 12. As seen in FIG. 7 and FIG. 8,aerosol generator 14 has a pair of locking tabs 78 that pass throughcorresponding tab slots 80 and snap into tab receptacles 82, as shown inFIG. 4. When locking tabs 78 on aerosol generator 14 are fitted into tabreceptacles 82 of actuator 12, inlet stem 84 of FIG. 8 is configured tofit to valve exit port 76 of actuator 12 as seen in FIG. 4, FIG. 5, andFIG. 6. Inlet stem 84 is mated with valve exit port 76 of actuator 12such that sealing is established between the base of inlet stem 84 andactuator outlet o-ring 88 of FIG. 6. This allows for fluid communicationbetween valve exit port 76 of actuator 12 and inlet stem 84 of aerosolgenerator 14 via valve exit conduit 74 of FIG. 6 and supply inlet 86 ofFIG. 8.

[0119] Referring now to FIG. 8 and FIG. 9, it can be seen that themetered volume of compressed gas received from the actuator 12 throughsupply inlet 86 of inlet stem 84, passes into supply channel 90 andproceeds into insert supply cavity 92 and out of the aerosolizationnozzle through jet orifice 94 and shock chamber 112.

[0120] In the embodiment shown, reservoir 38 of aerosol generator 14preferably has a liquid feed tube 96 mounted to liquid feed stem 98 thathas a medicine channel 100 that is in fluid communication with theaerosolization assembly 36 as seen in FIG. 8 and FIG. 9. Thus, liquidentrained for aerosolization from reservoir 38 is caused to travel upliquid feed tube 98, through medicine channel 100 of liquid feed stem 98and directly to the nozzle section of the aerosolization nozzle assembly36, which is shown in the enlarged detailed view of FIG. 9.

[0121] In one embodiment, the channel 100 may be sized or have anorifice that will restrict the flow of material through channel 100traveling to the nozzle assembly 36. This regulation of the volume ofmaterial or the rate of material introduced has been shown to increasethe efficiency of the aerosol process. Any restriction between thereservoir and the shock chamber would potentially serve the samepurpose.

[0122] In the embodiment shown in FIG. 8, aerosol generator 14 is madeof reservoir base 102, mouthpiece 104, elbow 106 and nozzle insert 108components. In this embodiment, the aerosol generator 14 is assembled byplacing liquid feed tube 96 on liquid feed stem 98 of mouthpiececomponent 104. Insert 108 is placed into the back of mouthpiece 104creating the critical nozzle geometry shown in FIG. 9 whereaerosolization occurs. Elbow 106 is placed into backside of insert 108and then the assembly consisting of mouthpiece 104, insert 108 and elbow106 are coupled with reservoir base 102. Plug 26 is then placed intoreservoir component 102. Bonding between mating pieces may beestablished using press fits, adhesive techniques, or ultrasonicwelding, except for mating between plug 26 and reservoir base 102, whichis intended to be a sliding fit.

[0123] Liquid medication intended for aerosolization is placed inreservoir 38 by removing plug 26 and placing the medication directlyinto the liquid storage cavity of reservoir 38. Various liquidmedications may be placed in the reservoir, as desired. In oneembodiment, the liquid storage cavity of reservoir 38 contains a totalvolume of at least twice the intended liquid volume to be dispensed.This allows for the prevention of spilling of the contents of the liquidstorage cavity of reservoir 38 and for different orientations of theaerosol generator 14.

[0124] An alternative to having a reservoir 38 for storing of medicationfor multiple doses, as above described, is to have means by which onedose may be made available to the aerosolization nozzle 36 at a giventime. This would be the preferred embodiment of the current inventionfor medication requiring very strict output control or which requiresspecial handling and storing, such as refrigeration. Strict outputcontrol would be realized because the aerosolization assembly 36 isdesigned so that it always attempts to entrain more liquid than there ispresent in the single dose reservoir. In this way, output is controlledsolely by what is in the reservoir and not the critical dimensions ofthe aerosolization nozzle assembly 36 or the contents of carbon dioxidecanister 28.

[0125] There exists many ways to have single dose reservoirs, includinga very small version of the previously described liquid storage cavity38, single ampules, or blister packs. A single dose may also includemultiple puffs until the medication in the reservoir or ampule isdepleted. In the case of ampules or blister pack cells, the liquid feedtube 96 would preferably be made from stiff plastic and would puncturethe ampule or blister pack cell when entrainment was desired. Afteractuation, the empty ampule would be discarded, or, in the case of theblister pack, the liquid feed tube 96 would be advanced to the nextblister pack cell when another dose of aerosol was required.

[0126] Still referring to FIG. 8, carbon dioxide gas supplied to supplyinlet 86, is caused to pass up supply conduit 90 and into insert supplycavity 92.

[0127] Referring also to FIG. 9, pressurized carbon dioxide gas that isprovided to insert supply cavity 92 is then caused to pass into jetorifice 94 with exit plane radius 110. In the preferred embodiment, jetorifice 94 has a diameter ranging from approximately 0.008 inches toapproximately 0.016 inches, and exit plane radius 110 preferably has adiameter ranging from approximately 0.010 inches to approximately 0.020inches. Although the exit plane radius with these dimensions ispreferred, any exit plane radius providing a characteristic jet can beused.

[0128] Because the supply pressure of the carbon dioxide canister isnormally approximately 750 psig, the jet formed in the jet orifice 94will go supersonic. The jet will remain supersonic until such time thatthe cross sectional area of the exit area, due to exit plane radius 110,becomes too large, at which point the jet will be over expanded andreflected shock waves will form in the jet as shown graphically in FIG.10 and schematically in FIG. 11. The diamond-shaped patterns of FIG. 10and FIG. 11 show the shock wave patterns in the supersonic jet.

[0129] In the preferred embodiment of the present invention, exit planeradius 110 is large enough to insure that the supersonic jet formed fromjet orifice 94 is over expanded. This will cause the first series ofreflected shock waves to be compression shock waves rather thanexpansion shock waves. Although expansion shock waves are capable ofaerosolization, compression shock waves have been shown to be moreeffective than expansion shock waves at aerosolization.

[0130] In an alternative configuration in which reflected expansionwaves are desired initially, exit plane radius 110 would be made smallenough, removed, or replaced with an appropriate taper, so that theexiting supersonic jet from jet orifice 94 was under expanded.

[0131] The supersonic jet exiting the jet orifice 94 and associated exitplane radius 110 will travel linearly down the central axis of shockchamber 112 and into the confines of mouthpiece 24. In the preferredembodiment, shock chamber 112 has a diameter ranging from approximately0.020 inches to approximately 0.030 inches, or two to three times thediameter of the jet orifice 94. The resulting reflecting shock waveswill continue along with the jet well outside the exit plane of shockchamber 112. Optimally, interstitial space 114 has a gap distancebetween the exit plane and jet orifice 94 and the inlet of shock chamber112 of between approximately 0.007 inches and 0.016 inches.

[0132] In general, the minimum pressure required to achieve supersonicflow in a nozzle with jet orifice 94 is dependant upon the ambientdischarge pressure and the supply pressure such that the ratio of thetwo should preferably be at least 0.5283 for air or oxygen and at least0.5457 for carbon dioxide. Since all known inhalers have alwaysdischarged into roughly atmospheric conditions (14.7 psi), the resultingminimum supply pressure can be determined as being approximately equalto 27.8 psi or 13.1 psig for air or oxygen and approximately 26.9 psi or12.2 psig for carbon dioxide. In theory, these minimum gas supplypressures are sufficient to produce a flow of gas through the throat ofa nozzle 94 with a velocity equal to the speed of sound. In practice, toproduce shock waves with sufficient strength to cause aerosolizationhigher pressures are required, other factors which make higher supplypressures more practical include pressure losses and the expansion ofgas into the internal volume of the device between the supply canister28 containing the stored gas and the cavity 92 of the nozzle assembly36. Although lower gas pressures will produce a degree ofaerosolization, superior results are achieved with even higher gaspressures or continual increases in output for higher pressures. Theincrease in output for higher pressures is due to the increasing speedof the supersonic jet and the resulting increase in strength of theresulting shock waves.

[0133] Supersonic jets produce shock waves in part because the jets donot expand gradually to the diameter of the shock chamber. Due to thenature of the fluid dynamics involved, and conservation of momentum,supersonic jets expand by producing shock waves, thus producing anextreme change in pressure from one side of a shock wave to the other.Unlike other exiting flow patterns, supersonic jets, through thedynamics of the shock waves, maintain roughly the same diameter that thejets had as they exited from the nozzle from which the jets wereproduced. Similarly, vacuum and entrainment of liquid is not primarilydue to the Bernoulli principle, but more to boundary layer frictionbetween the exiting jet and the surrounding gas in the shock chamber112.

[0134] It will be seen that any nozzle which supplies a compressed gasto the nozzle orifice at pressures above the calculated minimums willhave a supersonic jet exiting from it which is either over, under, orperfectly expanded, provided that there is nothing present to disturbthe jet, such as too much liquid material introduced to the jet. Anozzle may achieve a jet with a velocity that is greater than the speedof sound if it is supplied with sufficient supply pressure and has agradually increasing cross-sectional area downstream of the throat orchoke. The potential increase in jet velocity with increasingcross-sectional area is dependant on the total supply pressure.

[0135] For the perfectly expanded supersonic jet, the cross-sectionalarea of the jet is increased to the maximum that is possible for thegiven gas supply pressure, resulting in a supersonic jet with a shockwave entirely enveloping the jet. Although this is ideal for theproduction of aerosol, it is often impractical in practice because ofvariances in the gas supply pressure and the dimensional tolerances thatare required in the nozzle assembly.

[0136] An under expanded supersonic jet has a maximum cross-sectionalarea which is less than the perfectly expanded supersonic jet. Theextreme example of an under expanded jet is a simple orifice 94 with noincreasing cross sectional area. The result of a under expandedsupersonic jet is a series of expansion and compression reflected shockwaves, with the first shock waves immediately after the exit of the jetbeing expansion waves.

[0137] An over expanded supersonic jet has a maximum cross sectionalarea which is greater than the maximum cross sectional area of theperfectly expanded supersonic jet. The result is also a series ofreflected compression and expansion shock waves. In one embodiment, anover expanded supersonic jet is instigated by placing a large radius onthe exit edge of the nozzle. Upon the jet traveling through the throatand then subsequently along the radius, the initial response is for thejet to increase to a speed greater than the speed of sound followed byan over expansion of the jet, which will produce reflected shock waves.

[0138] Referring back to FIG. 8 and FIG. 9, upon the initial formationof the supersonic jet, a vacuum will be created in interstitial space114, which is in fluid communication with the medicine channel 100, thuscausing liquid medication to be entrained from reservoir 38 throughliquid feed tube 96, stem 98, channel 100 and introduced into shockchamber 112. Liquid stripped from interstitial space 114 initially formsdroplets, that are too large to be classified as aerosol. Uponentrainment into the jet, droplets become exposed to the largedifferentials in pressure and velocity that exist across a shock wave.These large differential pressures and velocities cause significantstretching of the droplet, thus increasing it's surface area. Due to thesurface tension of liquid, droplets resist having their surface areaincreased and, when stretched sufficiently, will break apart to formmultiple other smaller particles. The aerosol burst is carried out ofthe shock chamber 112 along with the expelled gas to mouthpiece 24.Subsequent to the initial fluid being introduced to shock chamber 112,the integrity of supersonic jet and resulting shock waves are destroyeddue to the ongoing entrainment of more liquid, although shock waves arestill present immediately proximal to the exit plane of jet orifice 94and exit plane radius 110. The duration of the shock waves can beaffected by restricting the flow of liquid such that the

[0139] Accordingly, the charging volume 72 is preferably made largeenough so as to deliver enough carbon dioxide gas to give the jet timeto form, entrain liquid, and create the desired burst of aerosol. Oncethe carbon dioxide that is delivered from charging volume 72 to the jetorifice 94 is depleted, the jet ceases to exist all together, and nomore liquid is entrained.

[0140] Referring also to FIG. 12, the aerosol exiting shock chamber 112is carried into the internal cavity 118 of mouthpiece 24 where it isavailable for immediate inhalation by the patient. FIG. 12 is a view ofthe aerosol generator 14 looking directly down the internal cavity 118of mouthpiece 24, the backside of the internal cavity 118 of mouthpiece24 is preferably equipped with four entrainment ducts 116, which allowambient air to be entrained when the patient inhales. The diameter ofthe mouthpiece internal cavity 118 and the cross-sectional area of thefour entrainment ports 116 are the primary means of controlling thegeometry and speed of escaping aerosol 120 from shock chamber 112 shownin FIG. 10.

[0141] The length of the mouthpiece 24 and its internal cavity 118 alsoplays a role in the speed of escaping aerosol. Accordingly, the lengthof mouthpiece 24 is reduced to a minimum to prevent as much waste ofaerosolized medication 120 as possible. In the current preferredembodiment, the mouthpiece internal cavity 118 has a diameter ofapproximately 0.775 inches and the preferred cross-sectional area of thefour-entrainment ducts 116 is approximately 0.08 inches squared or 0.02inches square for each duct 116. Reducing the cross-sectional area ofthe four-entrainment ducts 116 has been shown to reduce the exitvelocity of the resulting aerosol if desired. Additionally, in analternative embodiment, spacers and valve holding chambers are wellknown in the industry and can be connected directly to the outerdiameter of mouthpiece 24.

[0142] Referring now to FIG. 13 through FIG. 30, an alternativeembodiment of the invention is shown. As seen in FIG. 13, thisembodiment comprises three principal parts: a reusable actuator handle200, a disposable aerosol generator 202 and a disposable carbon dioxidecartridge assembly 204.

[0143] Turning now to FIG. 14 and FIG. 15 the gas supply (carbondioxide) cartridge assembly 204 can be seen. The cartridge assembly 204comprises a gas canister 206 and gas canister cap 208. The carbondioxide gas canister 206 preferably includes a top 210 with threads 268that is configured to engage with corresponding threads 266 within avalve assembly contained in actuator handle 200 as seen in FIG. 14 andFIG. 20. Although a gas canister 206 is preferred and used forillustration, it will be understood that other sourced of gas supplyknown in the art such as compressors or pumps and the like may be usedas a source of compressed gas.

[0144] Carbon dioxide gas represents only one of many different types ofgases that may be used to power the current invention. Although carbondioxide gas is preferred, it will be understood that any appropriatepressurized gas or combinations of gasses can be used. In oneembodiment, gas canister 206 is bonded to the gas canister cap 208 withan adhesive and is designed with a large diameter to allow forsufficient torque during insertion of the carbon dioxide cartridge 206into actuator handle 200. Carbon dioxide cartridge 206 preferably fitslongitudinally into the underside of actuator handle 200 throughcartridge port 212.

[0145] Turning now to FIG. 16 through FIG. 19, the components of theactuator handle 200 of the embodiment of FIG. 13 are shown. Actuatorhandle 200 has an elongate actuator body 214 with cartridge port 212 atthe bottom end. The actuator handle also includes a valve assembly 216,valve stem cover 218, trigger 220, and trigger pivot pin 222 as seen inthe exploded view of FIG. 17.

[0146] Valve stem cover 218 has a pair of valve stem cover bosses 224that engage angled edges 226 of trigger 220 such that when trigger 220pivots about pin 222 the valve stem cover 218 moves longitudinallywithin handle body 214. Accordingly, when assembled, valve stem cover218 mates with valve assembly 216 and the bosses 224 engage with trigger220 such that when trigger 220 is squeezed, trigger cam surface 226engages with valve stem bosses 224 such that valve stem cover 218 isforced to move downward causing valve assembly 216 to become actuated asdescribed herein.

[0147] Referring also to FIG. 18, FIG. 19 and FIG. 20, the components ofone embodiment a valve assembly 216 are shown. Valve assembly 216 has agenerally cylindrical body 228 that is configured to fit within actuatorhandle 200 as seen in FIG. 17 and FIG. 18. In this embodiment, valveassembly body 216 has one or more raised rails 230 on the outer surfacethat slide within corresponding slots in the interior of the handle 200(not shown) as well as slots 232 in valve stem cover 218. The raisedrail 230 and slot configuration securely positions the valve assemblyand eliminates any rotational motion of the valve assembly 216 when thethreads 268 of the top 210 of gas canister 206 are screwed into thethreads 268 of the valve assembly. Rails 230 also facilitate the linearmovement of the valve stem cover 218 with respect to the valve assembly216 when the trigger 220 is pressed.

[0148] Referring now to the exploded view of the valve assembly 216 inFIG. 19 and the cross sectional view of FIG. 20, the regulation of theflow of gas from the canister 206 through the stem exit port 236 can beseen. In the embodiment shown in FIG. 19, the valve assembly 216 has acanister seal 238, valve body 228, hollow canister puncture pin 240,puncture pin valve seal 242, valve spacer 244, central valve seal 246,cylinder 248 with chamber 250, stem plug 260, valve stem 234, top valveseal 252, and end plate 254. The exploded view in FIG. 19 shows therelative position of each of these components. The cross sectionalschematic view in FIG. 20 shows the relative position of the componentswhen assembled.

[0149] Seals 238, 242, 246 and 252 as well as stem plug 260 arepreferably made of urethane, due to the resistance of this material toreact with compressed carbon dioxide. Valve spacer 244 and cylinder 248are preferably made of injected molded nylon. Valve body 228, canisterpuncture pin 240, valve stem 234, and end plate 234 are preferably madeof machined aluminum but may also be made of glass-reinforced nylon. Inthe embodiment shown, the parts are assembled as shown in FIG. 19 andthen valve body end 256 is rolled over in a machining operation to keepthe parts in place.

[0150] Referring now to FIG. 20, the regulation of the gas flow and themovements of the valve components of one embodiment of the valveassembly can be seen. Valve stem 234 can move axially within chamber 250of cylinder 248. A circumferential flange 258 on stem 234 stops theoutward movement of stem 234 by engaging the interior side of the topvalve seal 252. Valve stem 234 is tubular and has a plug 260 in theapproximate center of the stem. In addition, stem 234 has a valve steminlet orifice 262 and a valve stem exit orifice 264 that communicatefrom the interior of the stem 234 to the exterior.

[0151] When the top 210 of carbon dioxide canister 206, for example, isadvanced on threads 266 of the valve assembly body 228, the top ofcanister 206 will engage hollow puncture pin 240, which pierces the top206. The top 210 of carbon dioxide canister 206 is caused to seatagainst canister seal 238 as the threads 269 of canister 206 areadvanced along the threads 266 of the valve body.

[0152] Once seated, carbon dioxide becomes available to valve assembly216 through canister puncture pin channel 270. The valve assembly 216 inthe normally closed position is shown in FIG. 20. In this position,valve stem 234 is pushed by the pressure of the compressed carbondioxide gas so that valve stem flange 258 is caused to seal against theupper valve seal 252.

[0153] In the closed position, carbon dioxide is allowed to pass fromthe canister 206 through pin channel 270, valve seal 242 and valvespacer 244 to valve stem inlet port 272 located at the proximal end ofstem 234. Gas within stem 234 must exit the stem through inlet orifice262 because of plug 252 to fill the chamber 250 of cylinder 248 thatexists between the outer diameter of valve stem 234 and the innerdiameter of valve cylinder 248. Valve seals 246 and 252 are sized on theinternal diameters to fit and seal against the outer diameter of valvestem 234. In the closed position, chamber 250 ultimately becomes filledwith carbon dioxide gas to the same pressure as that of canister 206.

[0154] In the open position, valve stem 234 is moved linearly, againstthe force of the internal pressure, toward the canister 206. It will beseen that when stem 234 is moved downwardly, valve stem inlet orifice262 is caused to pass by central valve seal 246 thereby disconnectingfluid communication between the carbon dioxide pressure provided by thecarbon dioxide cartridge 206 and interstitial space of chamber 250.Further motion of valve stem 234 causes valve stem exit orifice 264 topass through top valve seal 252 allowing the compressed gas in chamber250 to exit the chamber through stem exit orifice 264 to the interior ofvalve stem 234 and out through valve stem exit port 236. In thepreferred embodiment, the volume of gas that is discharged through stemexit port 236 is predictable and consistent for each actuation event andis determined by the relative internal volumes of jet 274 and the volumeof chamber 248. When the stem 234 is returned to the normally closedposition, the chamber 250 refills and becomes ready for the nextactuation.

[0155] Turning now to FIG. 21 through FIG. 28, 31 and 32, the preferredaerosol generator component of the present invention is described. Asseen in the exploded view of FIG. 22, the preferred aerosol generator202 comprises a jet 274, secondary 276, reservoir cup 278, cap 280,column base 282, column 284, flapper valve 286, and column end 288.

[0156] The jet 274, shown in FIG. 23, has a set of external threads 300that allow the aerosol generator 202 to fit onto actuator handle 200through the engagement of threads 300 with the corresponding threads 302of valve stem cover 218 as shown in FIG. 16. The distal end of valvestem 234 mates with the inside diameter of valve stem cover 218 toprovide an adequate seal. The interior of jet 273 is configured toreceive valve stem cover exit port 304 when the external threads 300 ofjet 274 are coupled with the valve stem cover 218. Jet 274 also has ajet orifice 306 that allows the flow of gas received from exit port 236from valve stem 234 through valve stem cover exit port 304.

[0157] Jet 274 and the secondary 276 shown in FIG. 24 interlock togethersuch that the external surfaces 308, 310 of jet 274 and the internalsurfaces of secondary channels 312, 314 of secondary 276, seen in FIG.25, to form interstitial fluid passages 316 seen in FIG. 31.

[0158] Secondary 276, shown in FIG. 24 and FIG. 25 also has an opening318 that operates as a shock chamber. As in the previously describedembodiment, jet orifice 306 mates with secondary 276 such that the shockchamber 318 and jet orifice 306 are aligned to form the shock waveaerosolization nozzle, and preferably have the same nozzle dimensions asdescribed in the first embodiment.

[0159] Secondary 276 fits into the bottom of reservoir cup 278 to form areservoir for the holding of liquid medication such that secondarysurface 320, shown in FIG. 24, preferably becomes the lowest point ofthe liquid reservoir. Penetrating through surface 320 through tosecondary channel 314 is liquid choke orifice 322. Liquid choke orifice322 provides further means, through the resistance of the flow ofliquid, for limiting the rate and amount of liquid entrained by theshock wave aerosolization nozzle. The preferred optimum size range forliquid choke orifice 322 is less than approximately 0.050 inches. Byfurther choking the flow of liquid down, it is possible to bettercontrol the volume and rate of introduction of fluid into the supersonicjet produced in the shock chamber, thus allowing for betteraerosolization and an increase in the duration of the aerosol burst.

[0160] Reservoir cup 278 mates with cap 280 through the engagement oflocking clips 324 on reservoir cup 278 shown in FIG. 22 with lockingmembers 326 as shown in FIG. 26. Reservoir cup 278 and cap 280 aredesigned to allow the exit plane of secondary 276 to protrude through abore 330 in cap 280 allowing for aerosol entry directly into aerosolchamber 340, while creating at the same time anti-spill ability forreservoir 332 as shown in FIG. 30. Anti-spill reservoir volume 332,shown in FIG. 30 is designed such that when invention is tipped sidewaysor upside down, liquid in reservoir does not spill out.

[0161] As seen in FIG. 26, cap 280 is preferably equipped with two pairsof protruding ribs 328 located on opposite sides of the cap which allowfor column base 282 and spacer column 284 to slide over cap 280 withoutrotating.

[0162] Column base 282, shown in FIG. 27, is equipped with mouthpiece334 to allow for patient inhalation. Column 284 is preferably tubularand configured to fit onto column base 282. Optionally, column base 282,column 284, and column end 288 may be made of anti-static plasticmaterial to prevent the loss of charged aerosol particles due to theattraction of the particles to oppositely charged aerosol chambersurfaces. Alternatively clear polycarbonate may also be used.

[0163] Referring now to FIG. 22 and FIG. 28, flapper valve 286 ispreferably a thin planar rubber circular piece that has a center holewhich fits over flapper valve post 336 of column end 288. Flapper valve286 preferably has a large enough outer diameter to encircle inhalationports 338. Column end 288 fits onto column 284 to form an aerosolizationchamber 340.

[0164] Once aerosol is produced from the jet 274 and shock chamber 318,it enters into the aerosolization chamber 340 of column 284 where it isstored until patient inhales on mouthpiece 334. Flapper valve 286prevents the patient from forcing stored aerosol out of chamber with anaccidental exhalation. Upon inhalation, flapper valve 286 allows roomair to be entrained into chamber 340.

[0165] Referring now to FIG. 29 and FIG. 30, the completed coupling ofthe aerosol generator 202, the actuator handle 200 and the gas canisterassembly 204 can be seen. The apparatus can be conveniently stored intwo pieces that are coupled prior to use. The full structure of thealternative embodiment of the apparatus of FIG. 13 can be seen in FIG.29 and FIG. 30.

[0166] Referring also to FIG. 31 and FIG. 32, in use gas from canister206 that has been previously seated on canister seal 238, enters thevalve assembly 216 through pin orifice 270. Gas enters chamber 250through valve stem inlet port 272 and valve stem inlet orifice 262 untilthe pressure of the gas in chamber 250 is equal to the pressure of thegas in canister 206. Upon actuation of trigger 220 as previouslydescribed, the contents of chamber 250 exits through valve stem outletorifice 264 and valve stem outlet port 236 as a burst of gas. The burstof gas travels through the internal conduit 342 of the valve stem cover218, and into the interior 344 of jet 274. Jet orifice 306 isdimensioned so that the jet formed in the jet orifice 306 will besupersonic producing the aerosolization process as described in thefirst embodiment. Additionally, jet orifice 306, and shock chamber 318preferably have the same dimensions and performance characteristics asthe first embodiment described herein.

[0167] Medicine held in reservoir 332 enters choke port 322 and channels312 and is drawn to interstitial space 346 between the jet 274 andsecondary 276 and aerosolized when brought in contact with thesupersonic jet. The aerosolized medication is then contained in theinterior chamber 340 of column 284 for inhalation by the patient.

[0168] Turning now to FIG. 33 and FIG. 34, an alternative embodiment ofthe invention is shown with reusable actuator handle assembly 350, gascartridge assembly 352, an aerosol generator 354, and an aerosol holdingchamber 356. In the embodiment shown, the aerosol generator 354 includesa shock wave amplification chamber 358 that extends into the aerosolholding chamber 356. An alternative embodiment of a shock waveamplification chamber is shown in FIG. 35. The aerosol generator 354 ispreferably composed of an aerosol generator head member 360 that isconfigured to receive an interlocking cap 362. In use, liquid medicineis placed in reservoir 364 in head 360 and then head 360 and cap 284 arecoupled together to form an enclosure. The chambers shown in FIG. 34 andFIG. 35 increase the volume of relatively small aerosol particles andgenerally separate and restrict larger aerosol particles from theaerosol storage column.

[0169] As shown in FIG. 33, the aerosol generator 354 connects to theactuator handle 350 by the engagement of threads 366 of the generatorhead 360. Upon actuation of the actuator, a small burst of CO₂ gas iscaused to exit the actuator 350 and travel into the inlet 368 of theaerosol generator head 360. The compressed CO₂ gas continues to travelup from inlet 368 into jet orifice 370. Due to the pressure built up bythe compressed CO₂ gas behind jet orifice 370, a sonic velocity jet iscaused to be formed in the orifice and a supersonic expansion is causedto occur in shock chamber 372 and liquid from reservoir 364 is entrainedby supersonic expansion jet into shock chamber 372 as describedpreviously. The resulting aerosol jet exiting from shock chamber 372 iscaused to pass down shock wave amplification chamber 358 in FIG. 34.

[0170] The shock wave amplification chamber 358 has a dual function thatgenerally increases the output and efficiency of suitably sizes aerosolparticles into aerosol holding chamber 356. One of the purposes of shockwave amplification chamber 358 is to capture the resulting spray andseparate large particles emitted by the aerosol jet from the generatorhead 360 that are too large for effective inhalation. Typically, theselarge particles were not entrained into the shock waves and thus werenever reduced down to a smaller particle size. This separation functionis primarily realized by the impacts and coalescing of these largeaerosol particles. Particles appropriately sized for inhalation (<10microns) are able to aerodynamically maneuver so as to avoid collisionwith the walls of the shock wave amplification chamber 358. Particles ofaerosol that are deposited on the walls of shock wave amplificationchamber 358 preferably accumulate and drip back into the reservoir 364to be aerosolized upon subsequent actuations.

[0171] A second function of the shock wave amplification chamber 358 isto reflect the acoustic energy generated by the supersonic expansion ofthe aerosol jet so as to generate more comparatively smaller aerosolparticles from the larger particles contained within the aerosol jet.Testing has shown that significantly more aerosol particles that aresuitably sized for respiration are generated with the shock waveamplification chamber 358 in place than generated without it, while theliquid entrained by the supersonic expansion of the jet remains thesame. This means that both the output and efficiency (i.e. the amount ofaerosol produced per the medication consumed) both increase. Theseimprovements in output and efficiency are very beneficial, especiallyfor delivery of expensive medications. The walls of the shock waveamplification chamber preferably are oriented at angles that reflectacoustic energy from the supersonic jet back on to the flow of aerosolparticles that are emitted from the nozzle and reduce the size of thelarger aerosol particles to smaller particles suitable for use.

[0172] In the embodiment shown in FIG. 33 and FIG. 34, the innerdiameter of the shock wave amplification chamber 358 is approximately0.375 inches and has a length of approximately 1.00 inch. Depending onthe desired output and efficiency, these dimensions may be variedaccordingly.

[0173] Turning now to FIG. 35, an additional embodiment of the shockwave amplification chamber is shown. As in the previous embodiment, thecap 374 is attached to the aerosol generator head 360. Carbon dioxide orother gas is caused to pass up inlet 368 and into jet orifice 370, andout shock chamber 372, causing entrainment of liquid from reservoir 364.The aerosol jet exiting shock chamber 372 is induced into formingadditional small particles within the aerosol stream by the reflectionof acoustic energy within the cavity formed by reservoir 364 and uppercap walls 376. The resulting aerosol exits from the aerosol outlet 378and into the aerosol holding chamber. The embodiments of FIG. 34 andFIG. 35 work similarly, although the embodiment of FIG. 34 is moreeffective at reducing residual liquid left in the device that isunavailable for further aerosolization with subsequent uses.

[0174] Referring specifically to FIG. 33, an alternative triggermechanism is shown that provides improved mechanical advantage andreduces the force necessary to actuate the apparatus. Upon squeezing oftrigger 380, it is caused to rotate about pivot point 382, thusproviding downward force on valve stem 384 and causing actuation ofvalve 386.

[0175] Referring also to FIG. 36, one embodiment of valve 386 is shownin cross-section. The principle parts of valve 386 are the valve body388, valve stem 384, valve insert 390, puncture pin 392, ball seal 394,and spring 396. Valve 386 also consists of O-rings 398, 400, 402, 404,and 406 as well as stop pins 408, 410, 412, and 414.

[0176] During assembly, the spring 396, ball seal 394, and o-ring 402are placed in puncture pin 392, which are then placed into valve insert390 and are held in place by an interference fit between puncture pin392 and valve insert 390. O-ring 398 is placed into valve insert 390,and o-ring 400 is placed in an o-ring groove that runs circumferentiallyaround valve insert 390. Valve insert 390 is then placed in valve body388 and held in place by cylindrical stop pins 408 and 410. Stop pins408 and 410 mate with valve body 388 and valve insert 390 by two throughholes that pass through valve body 388 and two external grooves in valveinsert 390. O-rings 404 and 406 are then placed in o-ring groovesrunning circumferentially around valve stem 384. Valve stem 384 is thenplaced in valve body 388 as shown and prevented from escaping byplacement of cylindrical stop pins 412 and 414, which fit into holespassing through valve body 388.

[0177] Carbon dioxide or other gas canisters are engaged with valve 386by threads 416, which ultimately causes the end of the gas canister tobe sealed against o-ring 398 and punctured by piercing point 418.ofpuncture pin 392 as the canister is advanced along the threads 416. Uponpuncture of the gas canister, compressed CO₂ gas is can travel throughpuncture pin gas passage 420, providing pressure against ball seal 394in conjunction with the force of spring 396 causing a seal between ballseal 394 and o-ring 402. This configuration represents the resting stateof valve 386.

[0178] Upon actuation of valve 386, valve stem 384 is caused to bepushed into valve 386 such that valve stem nose 422 is pushed againstball seal 394 resulting in the escape of gas around the ball seal 394into holding volume 424. Gas moving into holding volume 424 is preventedfrom escaping by o-ring 404 while the valve stem is in the actuatedposition allowing for the pressure of gas in holding volume 424 to reachthe same pressure as in the gas canister.

[0179] Upon release of the actuation force on valve stem 384, thepressure of the compressed CO₂ gas causes valve stem 384 to disengagewith ball seal 394, thus resealing the gas canister. Upon furtherdisengagement of valve stem 384, continued to be caused by compressedCO₂ gas in holding volume 424, o-ring 404 is caused to pass overlongitudinal gas escape grooves 426 and 428, releasing compressed gasheld in holding chamber 424 through valve stem gas inlet 430 and outvalve stem gas outlet 432 for delivery to the gas inlet of the aerosolgenerator as previously described and shown in FIG. 33.

[0180] Turning now to FIG. 37 through FIG. 41, one embodiment of ablister pack aerosol generator 434 according to the invention is shown.The jet orifice 436 is integral to the blister base 438 in thisembodiment. Positioned radially around jet orifice stem 440 are blisterholding cavities 442, 444, 446, and 448. In the embodiment shown, thereare four blister pack holding cavities. However, it will be understoodthat the number of blister pack cavities may be varied as desired.

[0181] It is preferred that the blister pack 450 be made of a lowdensity polyethylene, or some other material that is stable with longterm contact with the medication, and sealed by a foil cover 452 whichis also preferably coated with polyethylene or similar inert plasticmaterial. During assembly of one embodiment of the blister pack aerosolgenerator 434, medication is placed in blister 450 and sealed by foilcover 452, preferably by heat stamping. The sealed blister pack 450containing the medication is then placed in a blister cavity. Blisterpack 450 is preferably sized to be as high as the walls of the blistercavity 442 so that tops of each are congruent when assembled. Aftersealed blister 450 has been placed in blister holding cavity 442, forexample, safety strip 454 is inserted over jet orifice stem 440 toprotect the foil covers 452 of the blister packs from damage and torestrict use of the device.

[0182] Feed rod 456 is then placed in cap 458. As most readily shown inFIG. 38, FIG. 39A and FIG. 39B, feed rod 456 is equipped with acylindrical member with feed rod outlet 460 that fits into cap liquidinlet 462 located in cap 458. Once feed rod 456 is placed in cap 458,cap 458 is placed onto blister base 438 by engagement of jet orificestem 440 and jet receptacle 464 as shown in FIG. 38. The fit between jetorifice stem 440 and jet receptacle 464 is preferably sufficient toprevent accidental disengagement of the two parts. Safety strip 454prevents cap 458 from traveling to far down jet orifice stem 440 andfeed rod 456 from puncturing blister until ready for use. FIG. 39A showsthe aerosol generator with the safety strip 454 in position and FIG. 39Bshows the safety strip 454 removed and the blister base 438 and cap 458in the proper position for use.

[0183] Referring to FIG. 41, when a patient is ready for a treatment theblister pack aerosol generator 434 is fitted to the top of actuator 466,which as with the previous embodiment, is outfitted with a disposablegas cartridge 468, a trigger 470, and a aerosol holding chamber (notshown) which fits around the top of the actuator providing sufficientvolume for holding aerosol. Unlike the actuator of the otherembodiments, the actuator 466 of the blister design preferably has atrigger 470 that rotates up, allowing for the placement of the blisterpack aerosol generator 434 to be placed on top of the actuator. Afterplacement of aerosol generator 434, safety strip 454 is removed fromaerosol generator 434 by pulling out and away from the generator.Trigger 470 is then rotated back down approximately 180 degrees, and theaerosol holding chamber (not shown) is placed on the actuator as seen inFIG. 41.

[0184] With safety strip 454 removed, the squeezing of the trigger 470will force cap 458 downward by the engagement of trigger bosses 472 and474 with trigger 470. The downward movement of cap 458 causes feed rod456 to puncture foil cover 452 of the blister pack 450 and come incontact with the medication stored within blister 450. The apparatus isnow ready for aerosolization of the medication in the blister 450through one or more bursts of gas.

[0185] In one embodiment using the valve shown in FIG. 36, compressedCO₂ gas is not released through the jet orifice 436 until trigger 470has been released. With the release of trigger 470, carbon dioxide iscaused to pass through jet orifice 436 and into shock chamber 476 andthrough shock wave amplification chamber 478. Jet orifice 436, shockchamber 476, and shock wave amplification chamber 478 function as inpreviously described embodiments. The vacuum generated by the supersonicjet emitting from jet orifice 436 causes liquid to be entrained fromblister 450, through feed rod 456, through liquid choke orifice 480 andinto the shock chamber 476 for aerosol production. The liquid chokeorifice 480 functions as described in previous embodiments to controlaerosol production and increase efficiency by limiting the volume orrate of liquid exposed to the supersonic jet over time. Once aerosol hasbeen produced and deposited in aerosol holding chamber (not shown), thepatient simply inhales on the mouthpiece and draws the aerosolizedmedication into the lungs.

[0186] Preferably, the aerosol chamber is made transparent so as toprovide the patient with visual feedback on the production of aerosoland the subsequent inhalation of the aerosol. Blister pack aerosolgenerators 434 are intended for one treatment, which may consist of oneor many bursts and inhalations. After the treatment, blister packaerosol generator 434 may be disposed of in a refuse receptacle. Thecurrent embodiment has the advantage of being able to have multipleblisters packaged within a blister aerosol generator 434 for delivery ofcombinations of medication with each inhalation. This is particularlyuseful for components of medication that are not able to be storedtogether for long periods of time.

[0187] Likewise, the shock wave aerosolization process can beefficiently used with micronized powder in blister packs. Blister packs,containing one or more cells, may be used to store a pre-determinedamount of powder. Prior to aerosolization, a feed tube, which is influid communication with the shock wave aerosolization nozzle assembly,is inserted into the blister pack cell. Subsequent to the insertion ofthe feed tube in the blister pack, the gas valve is actuated, creating aset burst of gas. As previously described, the carbon dioxide exits thethroat of the jet, causing a vacuum, which entrains the micronizedpowder through the feed tube and into the shock chamber. As with liquidmedication, when medicinal powder is entrained it becomes efficientlyaerosolized with the reflected shock waves and carried out to themouthpiece or valve chamber for inhalation by the user.

[0188] In accordance with an alternative embodiment of the invention, asingle blister pack cartridge is shown in FIG. 42. The aerosolgenerating assembly including the jet and supersonic shock chamber isprovided in a small cartridge 482 along with a single blister pack 484containing sufficient medication for one aerosol treatment. In thissingle use embodiment, the cartridge 482 is to be inserted into the baseof the aerosol generator housing 486, which is coupled to the body 214of actuator handle 200 so as to cause the duct 488, jet 490 andsupersonic shock nozzle 492 to become oriented above the channel 342 ofvalve cover port 304. Cartridge 482 has an exterior housing that isconfigured to be disposed in a slot 494 within the base 486 by thepatient or care provider. After insertion into the base, cartridge 482is sealed to the outlet passage of carbon dioxide with o-ring 496.

[0189] The shock nozzle assembly portion of cartridge 482 has a jetorifice 490 as well as a shock chamber 492 that are preferablyconfigured and function as described in the previous embodiments.Adjacent to jet orifice 490 is liquid feed line 498 that is in fluidcommunication with prong 500.

[0190] Once cartridge 482 is inserted, aligned and seated in base 486,the apparatus is ready for use. The foil barrier 502 of blister pack 484is preferably punctured by the prong 500 by the user pressing the backwall 504 of cartridge 482 and sliding the foil barrier 502 of blisterpack 484 on to the prong 500. It can be seen that the medicine 506within blister pack 484 is now capable of being entrained from theblister pack 484 through liquid feed tube 498 and through to thesupersonic shock nozzle assembly.

[0191] Accordingly, when the trigger is depressed, gas is releasedthrough the bore 236 of the valve and out port 304 through channel 342into duct 488. The gas then passes through jet 490 and shock chamber492. As gas is caused to pass through the jet orifice 490 and shockchamber 492, the medicine 506 in the blister pack 484 is entrained andaerosolized by the supersonic shock nozzle as described with previousembodiments. Aerosol is directed to chamber 508 from the supersonicshock nozzle for inhalation by the patient.

[0192] Upon completion of the aerosol treatment, the supersonic shocknozzle/blister cartridge 482 may be removed and discarded by the user.This single use embodiment may work with or without an aerosol storagechamber and has the advantage of reducing possible contamination of thesupersonic shock nozzle between treatments.

[0193] It can be seen, therefore, that the present invention provides aninhaler device that can deliver a burst of aerosol from an aqueoussolution. In this way a number of advantages are realized which include,less expense on the part of the patient, less cost in formulationdevelopment, better aftertaste, portability, and convenience.

[0194] Although the description above contains many details, theseshould not be construed as limiting the scope of the invention but asmerely providing illustrations of some of the presently preferredembodiments of this invention. Therefore, it will be appreciated thatthe scope of the present invention fully encompasses other embodimentswhich may become obvious to those skilled in the art, and that the scopeof the present invention is accordingly to be limited by nothing otherthan the appended claims, in which reference to an element in thesingular is not intended to mean “one and only one” unless explicitly sostated, but rather “one or more.” All structural, chemical, andfunctional equivalents to the elements of the above-described preferredembodiment that are known to those of ordinary skill in the art areexpressly incorporated herein by reference and are intended to beencompassed by the present claims. Moreover, it is not necessary for adevice or method to address each and every problem sought to be solvedby the present invention, for it to be encompassed by the presentclaims. Furthermore, no element, component, or method step in thepresent disclosure is intended to be dedicated to the public regardlessof whether the element, component, or method step is explicitly recitedin the claims. No claim element herein is to be construed under theprovisions of 35 U.S.C. 112, sixth paragraph, unless the element isexpressly recited using the phrase “means for.”

What is claimed is:
 1. An apparatus for producing shock waveaerosolization, comprising: a nozzle; means associated with said nozzlefor generating a supersonic jet of gas from a source of compressed gas;means for introducing a volume of liquid within said supersonic jet ofgas; and means for regulating the introduction of said volume of liquidwithin said supersonic jet of gas, wherein a quantity of aerosol isproduced.
 2. An apparatus as recited in claim 1, further comprising asonic shock chamber configured for receiving said supersonic jet of gas.3. An apparatus as recited in claim 2, further comprising: a useractuated valve; and means for releasing a volume of compressed gas inbursts by said valve and delivering said supersonic jet of gas to saidshock chamber.
 4. An apparatus as recited in claim 3, furthercomprising: means for delivering a burst of compressed gas to saidnozzle and forming said supersonic jet prior to a material beingentrained and mixed with said jet.
 5. An apparatus as recited in claim1, further comprising: means for separating large aerosol particles fromsmall aerosol particles produced by said jet of gas.
 6. An apparatus asrecited in claim 5, wherein said means for separating large aerosolparticles from small aerosol particles comprises: an aerosol separator,said separator comprising a separator body with a central chamber and anaerosol outlet.
 7. An apparatus as recited in claim 1, furthercomprising: means for regulating a rate of introduction of said volumeof liquid that is entrained with said supersonic jet of gas.
 8. Anapparatus as recited in claim 7, wherein said means for regulating therate of introduction of a liquid into said supersonic jet comprises aliquid feed choke.
 9. An apparatus as recited in claim 1, wherein saidmeans for regulating the volume of a liquid introduced into saidsupersonic jet comprises a lumen associated with said nozzle configuredto entrain a desired volume within a burst of gas.
 10. An apparatus forproducing shock wave aerosolization, comprising: a nozzle; a useractuated valve associated with said nozzle adapted to generate asupersonic jet of gas; a material feed associated with said nozzleconfigured to introduce a volume of material within said supersonic jetof gas, wherein a quantity of aerosol is produced; and a material feedchoke.
 11. An apparatus as recited in claim 10, further comprising asonic shock chamber configured for receiving said supersonic jet of gas.12. An apparatus as recited in claim 10, further comprising: means forreleasing a volume of compressed gas in discrete bursts by said useractuated valve.
 13. An apparatus as recited in claim 12, furthercomprising: means for delivering a burst of compressed gas to saidnozzle and forming said supersonic jet prior to a material beingentrained and mixed with said jet.
 14. An apparatus as recited in claim10, further comprising: means for separating large aerosol particlesfrom small aerosol particles produced by said jet of gas.
 15. Anapparatus as recited in claim 14, wherein said means for separatinglarge aerosol particles from small aerosol particles comprises: anaerosol separator, said separator comprising, a separator body with acentral chamber and an aerosol outlet.
 16. An apparatus as recited inclaim 15, wherein said aerosol separator further comprises: a tubularbody continuous with said aerosol outlet and said central chamber ofsaid separator body.
 17. An apparatus as recited in claim 15, whereinsaid aerosol separator further comprises: means for reflecting acousticenergy from said supersonic jet within said central chamber of saidseparator body.
 18. An apparatus for producing shock waveaerosolization, comprising: a source of compressed gas; a supersonicshock nozzle; a user actuated valve configured to release saidcompressed gas in bursts for delivery through said supersonic shocknozzle; and an aerosol separator, wherein large aerosol particles can beseparated from small aerosol particles.
 19. An apparatus as recited inclaim 18, wherein said supersonic shock nozzle comprises: a jet orificeconfigured to receive compressed gas from said source of compressed gas;and a sonic shock chamber configured to receive compressed gasdischarged from said jet orifice.
 20. An apparatus as recited in claim19: wherein said jet orifice is configured to produce a supersonic jetfrom said compressed gas; and wherein said shock chamber is configuredto receive said supersonic jet and produce shock waves.
 21. An apparatusas recited in claim 20, wherein said supersonic jet is configured toestablish a series of reflected compression and expansion shock waves insaid shock chamber when said supersonic jet is over expanded or underexpanded.
 22. An apparatus as recited in claim 21, wherein saidsupersonic jet will be approximately the diameter of the jet orifice andtravel down the axis of the shock chamber.
 23. An apparatus as recitedin claim 21, wherein a cylindrical shock wave will be generated in saidshock chamber that envelopes the entire jet when said supersonic jet isperfectly expanded.
 24. An apparatus as recited in claim 21, whereinupon formation of said supersonic jet and resulting shock waves in saidshock chamber, a vacuum is generated which causes a liquid from a liquidreservoir to be entrained through a liquid feed into said shock chamber.25. An apparatus as recited in claim 24, wherein upon entrainment ofliquid into the shock chamber, the initial liquid entrained comes incontact with shock waves, producing aerosol particles suitable forinhalation.
 26. An apparatus as recited in claim 18, wherein saidaerosol separator comprises a separator body with a central chamber andan aerosol outlet.
 27. An apparatus as recited in claim 26, wherein saidaerosol separator further comprises: a tubular body continuous with saidaerosol outlet and said central chamber of said separator body.
 28. Anapparatus as recited in claim 18, wherein said aerosol separator furthercomprises: means for reflecting acoustic energy from said supersonic jetwithin said central chamber of said separator body.
 29. An apparatus asrecited in claim 28, wherein said means for reflecting acoustic energycomprises angular walls, wherein larger aerosol particles can be dividedinto smaller aerosol particles.
 30. An apparatus for producing aerosol,comprising: a source of compressed gas; means for generating asupersonic jet of gas from said source of compressed gas; means forintroducing material into said supersonic jet of gas to produce aerosolparticles; and means for separating large aerosol particles from smallaerosol particles.
 31. An apparatus as recited in claim 30, wherein saidmeans for generating said supersonic jet of gas comprises a nozzle. 32.An apparatus as recited in claim 31, wherein said means for introducingparticulates into said supersonic jet of gas comprises: a materialreservoir; and ducts associated with said nozzle, said ductscommunicating with said reservoir, wherein said material is introducedinto said jet of gas.
 33. An apparatus as recited in claim 30, furthercomprising: means for regulating the introduction of material into saidjet of gas.
 34. An apparatus as recited in claim 33, wherein said meansfor regulating the introduction of material into said jet of gascomprises an orifice.
 35. An apparatus as recited in claim 33, whereinsaid means for regulating the introduction of material into said jet ofgas comprises a liquid choke.
 36. An apparatus as recited in claim 30,further comprising: means for regulating the total volume of materialintroduced into said jet of gas.
 37. An apparatus as recited in claim30, wherein said material introduced into said supersonic jet of gascomprises a liquid.
 38. An apparatus as recited in claim 30, furthercomprising: means for delivering a discrete volume of compressed gas tosaid nozzle.
 39. An apparatus as recited in claim 38, wherein said meansfor delivering a discrete volume of compressed gas to said nozzlecomprises a metered valve.
 40. An apparatus as recited in claim 30,further comprising a sonic shock chamber configured for receiving saidsupersonic jet of gas.
 41. An apparatus for producing aerosol,comprising: a source of pressurized gas; a supersonic shock nozzle; areservoir of liquid in fluid communication with said nozzle; a meteredvalve configured to release said pressurized gas in bursts for deliverythrough said supersonic shock nozzle; and an aerosol separator coupledto said shock nozzle, wherein large aerosol particles are separated fromsmall aerosol particles.
 42. An apparatus as recited in claim 41,wherein said supersonic shock nozzle comprises: a jet orifice configuredto receive compressed gas from said source of pressurized gas; a lumenin fluid communication with said reservoir of liquid; and a sonic shockchamber configured to receive entrained liquid mixed with a jet ofcompressed gas discharged from said jet orifice.
 43. An apparatus asrecited in claim 42: wherein said jet orifice is configured to produce asupersonic jet from said compressed gas; and wherein said shock chamberis configured to receive said supersonic jet and produce shock waves.44. An apparatus as recited in claim 43, further comprising: means forregulating the introduction of liquid into said supersonic jet of gas.45. An apparatus as recited in claim 43, wherein said means forregulating the introduction of liquid into said jet of gas comprises anorifice.
 46. An apparatus as recited in claim 43, wherein saidsupersonic jet is configured to establish a series of reflectedcompression and expansion shock waves in said shock chamber when saidsupersonic jet is over expanded or under expanded.
 47. An apparatus asrecited in claim 46, wherein said supersonic jet is configured to beapproximately the diameter of the jet orifice and travel down the axisof the shock chamber.
 48. An apparatus as recited in claim 43, wherein acylindrical shock wave is generated in said shock chamber that envelopesthe entire jet when said supersonic jet is perfectly expanded.
 49. Anapparatus as recited in claim 43, wherein upon formation of saidsupersonic jet and resulting shock waves in said shock chamber, liquidfrom said liquid reservoir is entrained through a liquid feed into saidshock chamber.
 50. An apparatus as recited in claim 49, wherein uponentrainment of liquid into the shock chamber, the initial liquidentrained comes in contact with shock waves, producing aerosol particlessuitable for inhalation.
 51. An apparatus as recited in claim 41,wherein said aerosol separator comprises a separator body with a centralchamber and an aerosol outlet.
 52. An apparatus as recited in claim 51,wherein said aerosol separator further comprises: a tubular bodycontinuous with said aerosol outlet and said central chamber of saidseparator body.
 53. An apparatus as recited in claim 41, wherein saidaerosol separator further comprises: means for reflecting acousticenergy from said supersonic jet within said central chamber of saidseparator body.
 54. An apparatus as recited in claim 53, wherein saidmeans for reflecting acoustic energy comprises angular walls, whereinlarger aerosol particles can be divided into smaller aerosol particles.55. An apparatus as recited in claim 41, further comprising: means forstoring produced aerosol.
 56. An apparatus as recited in claim 55,wherein said means for storing produced aerosol comprises an enclosure.57. An apparatus as recited in claim 56, said enclosure furthercomprising: an ambient air intake port; and a mouthpiece, wherein theaerosol contents of said enclosure can be inhaled by the user.
 58. Anapparatus as recited in claim 57, said intake port further comprising: adirectional valve, wherein the movement of the contents to and from saidenclosure can be regulated.
 59. An apparatus as recited in claim 41,further comprising: an actuator handle, said actuator valve coupled tosaid handle; and a trigger operably coupled to said actuator valve. 60.An apparatus as recited in claim 59, wherein said actuator handle isconfigured to receive a cartridge.
 61. An apparatus as recited in claim60, further comprising: a cartridge containing said nozzle and areservoir containing liquid for aerosolization dimensioned for insertioninto said handle.
 62. An apparatus as recited in claim 61, wherein saidreservoir containing liquid comprises a blister pack.
 63. An apparatusas recited in claim 61, wherein said cartridge is disposable.
 64. Anapparatus as recited in claim 61, wherein insertion of said cartridgeinto said actuator handle causes said nozzle to be sealed with an outletpassage of said compressed gas source upon actuation of the actuatorvalve.
 65. An apparatus as recited in claim 62, wherein insertion ofsaid cartridge into said actuator handle causes said blister pack to bepunctured.
 66. A method for producing an aerosol suspension comprising:directing a flow of gas through a nozzle to form a supersonic jet ofgas; and introducing material into the supersonic jet of gas to producean aerosol suspension.
 67. A method for producing an aerosol suspensionas recited in claim 66, further comprising: controlling said flow of gasthrough said nozzle.
 68. A method for producing an aerosol suspension asrecited in claim 67, wherein said controlling of said flow of gascomprises: directing said flow of gas through said nozzle in bursts. 69.A method for producing an aerosol suspension as recited in claim 66,further comprising: directing said supersonic jet of gas through a sonicshock chamber.
 70. A method for producing an aerosol suspension asrecited in claim 67, wherein said supersonic jet of gas is overexpanded.
 71. A method for producing an aerosol suspension as recited inclaim 67, wherein said supersonic jet of gas is under expanded.
 72. Amethod for producing an aerosol suspension as recited in claim 67,wherein said supersonic jet of gas is perfectly expanded.
 73. A methodfor producing an aerosol suspension as recited in claim 69, furthercomprising: establishing a series of reflected compression and expansionshock waves in said shock chamber when said supersonic jet of gas isdirected through said sonic shock chamber.
 74. A method for producing anaerosol suspension as recited in claim 66, further comprising:regulating the volume of material introduced into said supersonic jet ofgas.
 75. A method for producing an aerosol suspension as recited inclaim 66, further comprising: regulating the rate of introduction ofmaterial that is introduced into said supersonic jet of gas.
 76. Amethod for producing an aerosol suspension as recited in claim 66,further comprising: separating small aerosol particles from largeaerosol particles produced by said supersonic jet of gas.
 77. A methodfor producing an aerosol suspension as recited in claim 66, furthercomprising: reflecting acoustic energy through produced aerosolparticles, wherein the size of said produced aerosol particles isreduced.
 78. A method for producing an aerosol suspension as recited inclaim 76, further comprising: storing separated small aerosol particles.